Quanterix has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Simoa neurofilament light chain (NfL) plasma test.
The test is meant to aid in the assessment of the risk of disease activity in patients diagnosed with relapsing-remitting MS (RRMS).
The designation will allow Quanterix to accelerate the development, assessment, and review processes for Simoa.
According to Quanterix, the Simoa test is a digital immunoassay that analyses NfL in human blood and plasma to identify RRMS patients who are at reduced or greater risk of relapse within four years when combined with clinical, imaging, and laboratory data.
Quanterix chairman and chief executive officer Kevin Hrusovsky said: “For the more than two million people suffering from MS worldwide, there’s an important need for more informed and effective treatment options.
“Obtaining FDA breakthrough device designation for our plasma NfL MS test was a key objective for 2022.
“We are pleased to have the opportunity to work with the FDA to help advance the Quanterix Simoa NfL test towards regulatory approval.”
The FDA’s breakthrough designation comes after a large-scale study published in The Lancet Neurology, conducted by the University Hospital Basel and the University of Basel to use Simoa technology for the identification and interpretation of elevated values of sNfL in MS patients.
Ottawa Hospital multiple sclerosis research director Dr Mark S. Freedman said: “There has been an ever-growing body of research with the Simoa NfL blood test supporting NfL as a reliable biomarker for MS disease activity prognosis and treatment response monitoring.
“The FDA’s grant of Breakthrough Device designation for this test has the potential to help the multiple sclerosis community further advance the optimal use of NfL measurements in both research and clinical practice aimed at more effective therapeutic management of the disease for the millions of patients suffering from the condition.”
In October last year, Quanterix’s phospho-Tau 181 (pTau-181) assay for Alzheimer’s disease received the breakthrough device designation.
